The National Pharmaceutical Control Bureau (NPCB), formerly known as the National Pharmaceutical Control Laboratory, was set up in October 1978 under the quality control activity of Pharmacy and Supply Programme. This institution was established to implement quality control on pharmaceutical products. The infrastructure and facilities were designed to meet the requirements for testing and quality control activities.

Beginning 1985, NPCB was given the task of ensuring the quality, efficacy and safety of pharmaceuticals through the registration and licensing scheme. This is achieved through evaluation of scientific data and laboratory tests on all products before they are marketed. A system to monitor products in the market was set-up. Information on drugs to medical profession and consumer was made available through a drug information service.

The NPCB also handles courses and provides training to personnel from the ASEAN countries, for example from Sri Lanka, Bangladesh, Myanmar, Mongolia and Vietnam.

In 1996, NPCB was given an international recognition by the World Health Organisation (WHO) as a "WHO Collaborating Centre for Regulatory Control of Pharmaceuticals". This recognition is an acknowledgement from WHO for NPCB's contribution in the field of regulatory affairs.

To be an internationally renowned regulatory authority for medicinal products and cosmetics.

To safeguard the nation’s health through scientific excellence in the regulatory control of medicinal products and cosmetics.

To ensure that therapeutic substances approved for the local market are safe, effective and of quality and also to ensure that cosmetic products approved are safe and of quality.